Comparison of Arthroscopic Supraspinatus Tendon Tear Repair in Patients Over 60 Years With and Without Patch Augmentation.
NCT ID: NCT03511547
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-01-01
2021-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group 1: Pitch-Patch
Reconstruction with patch augmentation using a synthetic patch
Pitch Patch
The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a synthetic (Pitch-Patch™ \[PP\]) augmentation.
Intervention group 2: ArthroFlex
Reconstruction with patch augmentation using a biological human dermis patch
ArthroFlex
The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a biologic patch (ArthroFlex® \[AF\]) augmentation.
Control
No interventions assigned to this group
Interventions
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Pitch Patch
The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a synthetic (Pitch-Patch™ \[PP\]) augmentation.
ArthroFlex
The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a biologic patch (ArthroFlex® \[AF\]) augmentation.
Eligibility Criteria
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Inclusion Criteria
* Indicated for surgical reconstruction by arthroscopy
* Patient aged 60 years and over
* Consenting participation in this study by signing the Informed Consent form
Exclusion Criteria
* Advanced fatty infiltration of the rotator cuff muscles (Goutallier grade III or IV)
* Tear of the subscapularis \> Typ 1 Lafosse (partial tears of superior 1/3 of the tendon)
* Irreparable tear of the supraspinatus
* General medical contraindication to surgery
* Known hypersensitivity to the materials used
* Revision operations
* Open reconstruction
* Tendon transfer necessary (latissimus dorsi or pectoralis major)
* Any disease process that would preclude accurate evaluation including:
* Systemic arthritis, rheumatoid arthritis, diabetes (insulin dependent), acute or chronic infection, abnormal bone metabolism, tumour / malignoma, psychiatric disorder
* Inadequate blood flow or neuromuscular disease in the affected arm
* Recent history of substance abuse
* Legal incompetence
* German language barrier to complete the questionnaires or
* Participation in any other medical device or medicinal product study that could influence the results of the present study
60 Years
ALL
No
Sponsors
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Schulthess Klinik
OTHER
Responsible Party
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Principal Investigators
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Markus Scheibel, Prof
Role: PRINCIPAL_INVESTIGATOR
Schulthess Klinik
Other Identifiers
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ARCR-RCT
Identifier Type: -
Identifier Source: org_study_id
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